A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Skin Care

Treatments: Other: Reference product; Other: Prototype disinfectant spray formulation; Other: Negative control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02106403

202273

RH02332 (Other Identifier)

Details and patient eligibility

About

The objective of this randomised, examiner and subject blinded study is to evaluate and compare cooling performance and overall consumer liking of the prototype formulation with the currently marketed wound spray and negative control in subjects with experimental wounds. For each subject, three superficial wounds will be induced on two volar forearms, by sequential tape strippings until a glistening layer is visualized. After wounding, a randomised test product will be sprayed twice on test site, and the subject will be asked to complete a questionnaire evaluating product cooling performance and overall liking.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in good health with healthy and intact skin on the test area
• Age 18-60 years

Exclusion criteria

• Pregnancy or breast-feeding
• Allergy/Intolerance
• Participants currently taking any topical or systemic treatments that may interfere with or mask the test results
• Participants who have taken any topical anti-inflammation treatment in the application area in past 2 months
• Participants who are vulnerable to any intervention
• Damaged skin close to test site, active skin disorders, any visible skin disorder

Trial design

50 participants in 3 patient groups, including a placebo group

Prototype disinfectant spray formulation

Experimental group

Description:

0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Treatment:

Other: Prototype disinfectant spray formulation

Reference product

Active Comparator group

Description:

0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Treatment:

Other: Reference product

Negative control

Placebo Comparator group

Description:

0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound

Treatment:

Other: Negative control